80_FR_28720 80 FR 28624 - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Withdrawal of Compliance Policy Guide; Section 608.400 Compounding of Drugs for Use in Animals

80 FR 28624 - Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability; Withdrawal of Compliance Policy Guide; Section 608.400 Compounding of Drugs for Use in Animals

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 96 (May 19, 2015)

Page Range28624-28629
FR Document2015-11982

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI) #230 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' The draft guidance describes FDA's policies with regard to compounding animal drugs from bulk drug substances. When final, the guidance will reflect FDA's current thinking on the issues addressed by the guidance. FDA is also announcing the withdrawal of the compliance policy guide (CPG) entitled ``Section 608.400 Compounding of Drugs for Use in Animals,'' which was issued in July 2003. This 2003 CPG is being withdrawn because it is no longer consistent with FDA's current thinking on the issues it addresses.

Federal Register, Volume 80 Issue 96 (Tuesday, May 19, 2015)
[Federal Register Volume 80, Number 96 (Tuesday, May 19, 2015)]
[Notices]
[Pages 28624-28629]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11982]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-D-1176 and FDA-2003-D-0202]


Compounding Animal Drugs From Bulk Drug Substances; Draft 
Guidance for Industry; Availability; Withdrawal of Compliance Policy 
Guide; Section 608.400 Compounding of Drugs for Use in Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry (GFI) #230 entitled 
``Compounding Animal Drugs from Bulk Drug Substances.'' The draft 
guidance describes FDA's policies with regard to compounding animal 
drugs from bulk drug substances. When final, the guidance will reflect 
FDA's current thinking on the issues addressed by the guidance.
    FDA is also announcing the withdrawal of the compliance policy 
guide (CPG) entitled ``Section 608.400 Compounding of Drugs for Use in 
Animals,'' which was issued in July 2003. This 2003 CPG is being 
withdrawn because it is no longer consistent with FDA's current 
thinking on the issues it addresses.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that FDA considers your comment on the draft 
guidance before it begins work on the final version of the guidance, 
submit either electronic or written comments on the draft guidance by 
August 17, 2015. Submit written or electronic comments on the proposed 
collection of information by August 17, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Policy and Regulations Staff (HFV-6), Center for 
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855. Send one self-addressed adhesive label to assist 
that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance.
    Submit electronic comments on the draft guidance, including 
comments regarding the proposed collection of information, to http://www.regulations.gov. Submit written comments on the draft guidance, 
including comments regarding the proposed collection of information, to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: With regard to this draft guidance: 
Division of Compliance, Center for Veterinary Medicine, Food and Drug 
Administration (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240-
402-7001, CVMCompliance@fda.hhs.gov.
    With regard to the proposed collection of information: FDA PRA 
Staff, Office of Operations, Food and Drug Administration, 8455 
Colesville Rd.; COLE-14526, Silver Spring, MD 20993-0002; 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Draft Guidance

    FDA is announcing the availability of a draft GFI #230 entitled 
``Compounding Animal Drugs from Bulk Drug Substances.'' The draft 
guidance provides information to compounders of animal drugs and other 
interested stakeholders on FDA's application of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act) with respect to the compounding of 
animal drugs from bulk drug substances.\1\
---------------------------------------------------------------------------

    \1\ FDA regulations define ``bulk drug substance'' as ``any 
substance that is represented for use in a drug and that, when used 
in the manufacturing, processing, or packaging of a drug, becomes an 
active ingredient or a finished dosage form of the drug, but the 
term does not include intermediates used in the synthesis of such 
substances.'' 21 CFR 207.3(a)(4). ``Active ingredient'' is defined 
as ``any component that is intended to furnish pharmacological 
activity or other direct effect in the diagnosis, cure, mitigation, 
treatment, or prevention of disease, or to affect the structure or 
any function of the body of man or other animals. The term includes 
those components that may undergo chemical change in the manufacture 
of the drug product and be present in the drug product in a modified 
form intended to furnish the specified activity or effect.'' 21 CFR 
210.3(b)(7). Any component other than an active ingredient is an 
``inactive ingredient.'' See 21 CFR 210.3(b)(8). Inactive 
ingredients used in compounded drug products commonly include 
flavorings, dyes, diluents, or other excipients.

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[[Page 28625]]

    Sections 503A (21 U.S.C. 353a) and 503B (21 U.S.C. 353b) of the 
FD&C Act do not apply to the compounding of animal drugs. The FD&C Act 
does not distinguish between compounding animal drugs from bulk drug 
substances and any other manufacturing or processing of animal drugs. 
Except with respect to the limited exemption provided by the FD&C Act 
described in this document, statutory provisions applicable to 
manufactured animal drugs under the FD&C Act also apply to compounded 
animal drugs.
    Section 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4) and 
(5)), provide a limited exemption from certain requirements for use for 
compounded animal drugs made from already approved animal or human 
drugs. Such use is considered an extra-label use and the FD&C Act 
provides that a compounded drug is exempt from the approval 
requirements and requirements of section 502(f)(1) (21 U.S.C. 
352(f)(1)) of the FD&C Act, if it meets the conditions set out in the 
statute and the extra-label use regulations at 21 CFR part 530.
    This draft guidance does not address the compounding of animal 
drugs from approved animal or human drugs pursuant to the extra-label 
provisions of the law, nor does it address the repackaging of approved 
animal drugs. FDA is considering whether guidance is needed on those 
issues, and if so, will publish separate guidances. In section III, FDA 
is asking for comment on specific questions about several issues 
including the practice of compounding from approved animal and human 
drugs and the repackaging of drugs for animal use to help determine 
whether additional guidance is necessary on these topics.
    This draft guidance describes conditions under which FDA does not 
generally intend to initiate enforcement action against State-licensed 
pharmacies, licensed veterinarians, and facilities registered as 
outsourcing facilities under section 503B of the FD&C Act (outsourcing 
facilities) that compound animal drugs from bulk drug substances. The 
draft guidance provides that FDA does not generally intend to take 
action under sections 512(a), 501(a)(5) (21 U.S.C. 351(a)(5)), 
501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), and 502(f)(1) of the FD&C Act if 
a State-licensed pharmacy or a licensed veterinarian compounds drugs 
intended for use in animals from bulk drug substances in accordance 
with all of the applicable conditions set out in the guidance. In 
addition, the draft guidance provides that FDA does not generally 
intend to take action under sections 512(a), 501(a)(5), and 502(f)(1) 
of the FD&C Act if the drug product is compounded from a bulk drug 
substance by an outsourcing facility and that meets all of the 
applicable conditions set out in the guidance, and the drug product is 
compounded from a bulk drug substance that appears on Appendix A of the 
draft guidance.
    Importantly, the draft guidance provides that FDA generally intends 
to enforce all other adulteration and misbranding provisions of the 
FD&C Act against entities compounding animal drugs from bulk drug 
substances.
    To ensure FDA can timely identify and address safety issues related 
to animal drugs compounded from bulk drug substances, one of the 
conditions, if met, under which FDA does not generally intend to take 
action for violations of the provisions described previously is that 
State-licensed pharmacies and veterinarians report any product defect 
or serious adverse event associated with animal drugs they compound 
from a bulk drug substance to FDA, within 15 days of becoming aware of 
them, using Form FDA 1932a. FDA intends to use these adverse event 
reports to identify animal drugs compounded from bulk drug substances 
that present serious risks to animal health. Unlike for human drugs, 
there are no State Departments of Health or Federal Agencies, such as 
the Centers for Disease Control and Prevention (CDC), which are 
responsible for identifying and tracing the source of injury and/or 
disease in animals. Adverse event reporting regarding drugs compounded 
from bulk drug substances by compounding pharmacies and veterinarians 
will provide a mechanism for FDA to identify and possibly prevent 
adverse events associated with compounded animal drugs. This is another 
topic on which we are requesting specific comment in section III.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a notice soliciting nominations for bulk drug substances that should be 
included in Appendix A, ``List of Bulk Drug Substances That May Be Used 
By an Outsourcing Facility to Compound Drugs for Use in Animals.'' The 
notice also describes the information that should be provided to the 
Agency in support of such nominations.

II. Withdrawal of 2003 Compliance Policy Guide

    In a notice published in the Federal Register of July 14, 2003 (68 
FR 41591), FDA announced the availability of CPG Section 608.400 of the 
Compliance Program Guidance Manual entitled, ``Compounding of Drugs for 
Use in Animals.'' This document is being withdrawn because it is no 
longer consistent with FDA's current thinking on the issue it 
addresses. The current CPG does not focus on the three main concerns 
FDA has about animal drug compounding: compounding copies of approved 
animal or human drugs from bulk drug substances, compounding for food-
producing animals from bulk drug substances, and compounding office 
stock from bulk drug substances. Because the CPG does not reflect FDA's 
current thinking, to leave it in effect until this draft guidance is 
finalized may confuse stakeholders about FDA's current enforcement 
priorities. Stakeholders should be aware that, until this draft 
guidance is finalized, FDA intends to look at the totality of the 
circumstances when determining whether to take enforcement action for 
unlawful animal drug compounding activities.

III. Specific Topics for Comment

    In addition to comments on the draft guidance as written, we are 
specifically requesting comments on the following issues:
     Should the final guidance address the issue of FDA-
approved animal and human drugs that are in shortage or are otherwise 
unavailable (e.g., disruptions in the manufacture or supply chain; 
business decisions to stop marketing the drug; drug is subject to 
Agency action based on safety, effectiveness, or manufacturing 
concerns)? If so:
    [cir] How should these situations be addressed in the final 
guidance?
    [cir] How should the final guidance define the terms ``shortage'' 
and ``unavailable''?
    [cir] What criteria should FDA use to determine if an approved 
animal or human drug is in shortage or otherwise unavailable?
     Do United States Pharmacopeia and National Formulary (USP-
NF) \2\

[[Page 28626]]

chapters <795> and <797> provide suitable standards for animal drugs 
compounded by veterinarians, and if not, what standards of safety, 
purity, and quality should apply to animal drugs compounded by 
veterinarians?
---------------------------------------------------------------------------

    \2\ Chapters <795> ``Pharmaceutical Compounding--Nonsterile 
Preparations'' and <797> ``Pharmaceutical Compounding--Sterile 
Preparations'' can be found in the combined United States 
Pharmacopeia and National Formulary (USP-NF), available at http://www.usp.org/.
---------------------------------------------------------------------------

     Should licensed veterinarians be able to sell or transfer 
an animal drug compounded from bulk drug substances by a State-licensed 
pharmacy or an outsourcing facility to owners or caretakers of animals 
under the veterinarian's care?
     How should FDA apply the condition to identify an 
individual patient when it is not possible to identify an individual 
animal (e.g., koi in a koi pond)?
     Should the final guidance include a condition on the 
amount or percentage of compounded animal drugs that a pharmacy or 
outsourcing facility can ship in interstate commerce? If so, what would 
a reasonable amount be?
     Should facilities registered as outsourcing facilities 
under section 503B of the FD&C Act be able to compound animal drugs 
from bulk drug substances that do not appear on Appendix A for an 
individually identified animal patient under conditions similar to 
those applicable to state-licensed pharmacies (i.e., the conditions 
contained in section III.A. of the draft guidance)?
     Is additional guidance needed to address the repackaging 
of drugs for animal use?
    [cir] How widespread is the practice of repackaging drugs for 
animal use?
    [cir] What types of drugs are repackaged for animal use, and why 
are they repackaged?
    [cir] Have problems been identified with repackaged drugs for 
animal use?
     Is additional guidance needed to address the compounding 
of animal drugs from approved animal or human drugs under section 
512(a)(4) or (a)(5) of the FD&C Act and part 530?
     Is additional guidance needed to address the compounding 
of animal drugs from bulk drug substances for food-producing animals?
     As one condition under which FDA does not generally intend 
to take action for certain violations of the FD&C Act if this and the 
other conditions are followed, FDA is proposing that State-licensed 
pharmacies and veterinarians report any product defect or serious 
adverse event associated with animal drugs they compound from bulk drug 
substances to FDA within 15 days of becoming aware of the product 
defect or serious adverse event. Outsourcing facilities are required to 
report adverse events associated with the drugs they compound. FDA 
believes it is important to receive this information from State-
licensed pharmacies and veterinarians because there are no other State 
Departments of Health or Federal Agencies (e.g., the CDC) charged with 
identifying and tracing animal injuries or disease associated with an 
animal drug compounded by these entities. FDA has the following 
specific questions with respect to this proposed condition:
    [cir] How many State-licensed pharmacies and veterinarians compound 
animal drugs from bulk drug substances and would potentially be 
reporting product defects and serious adverse events to FDA?
    [cir] Are State-licensed pharmacies and veterinarians reporting the 
same or similar information to any State regulatory agency (e.g., State 
boards of pharmacy, State boards of veterinary medicine)? If so, how 
many reports on average does each State-licensed pharmacy and 
veterinarian submit to these State agencies each year?
    [cir] For purposes of the guidance, how should FDA define the terms 
``product defect'' and ``serious adverse event''?
    [cir] Can FDA achieve the same objective of identifying and tracing 
the source of injuries or disease associated with an animal drug 
compounded from a bulk drug substance through means other than product 
defect and serious adverse event reporting, and if so, what other 
means? For example, would reports of product defects alone achieve the 
same objective?

IV. Significance of Guidance

    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on 
compounding animal drugs from bulk drug substances. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

V. Paperwork Reduction Act of 1995

    This draft guidance contains proposed information collection 
provisions that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520). ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal Agencies to provide a 
60-day notice in the Federal Register for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, we invite comments on these topics: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimate of the 
burden of the proposed collection of information, including the 
validity of the methodology and assumptions used; (3) ways to enhance 
the quality, utility, and clarity of the information to be collected; 
and (4) ways to minimize the burden of the collection of information on 
respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.
    Title: Compounding Animal Drugs from Bulk Drug Substances (OMB 
Control Number 0910-NEW)
    Description of Respondents: The proposed collection of information 
would affect State-licensed pharmacies, licensed veterinarians, and 
outsourcing facilities that compound animal drugs from bulk drug 
substances.
    Description: This draft guidance describes FDA's current thinking 
regarding compounding animal drugs from bulk drug substances and 
describes the conditions under which FDA does not generally intend to 
take action for violations of the following sections of the FD&C Act: 
512, 501(a)(5), 502(f)(1), and, where specified, 501(a)(2)(B), when a 
State-licensed pharmacy, licensed veterinarian, or an outsourcing 
facility compounds animal drugs from bulk drug substances. The draft 
guidance provides three sets of conditions, one for each entity: State-
licensed pharmacies, licensed veterinarians, and outsourcing 
facilities.
    This draft guidance only addresses the compounding of animal drugs 
from bulk drug substances. It does not apply to the compounding of 
animal drugs from approved new animal or new human drugs. Such 
compounding can be conducted in accordance with the provisions of 
section 512(a)(4) and (5) of the FD&C Act and part 530. In addition, 
this guidance does not address the compounding of drugs intended for 
use

[[Page 28627]]

in humans, which is addressed in other guidances.
    FDA estimates the burden of this collection of information as 
follows:

Reporting

    This draft guidance contains no new reporting provisions. This 
draft guidance refers to previously approved collections of information 
found in FDA regulations. These collections of information are subject 
to review by OMB under the PRA. The collections of information 
regarding voluntary reporting of adverse drug experiences or product/
manufacturing defects on Form FDA 1932a, ``Veterinary Adverse Drug 
Reaction, Lack of Effectiveness or Product Defect Report,'' have been 
approved under OMB control number 0910-0284; the information collection 
provisions regarding establishment registration under section 510 of 
the FD&C Act (21 U.S.C. 360) have been approved under OMB control 
number 0910-0777. This draft guidance also refers to proposed 
collections of information regarding drugs made by an outsourcing 
facility during the previous 6-month period as described in FDA's 
notice of November 24, 2014 (79 FR 69857), announcing the availability 
of a draft guidance entitled ``Electronic Reporting for Human Drug 
Compounding Outsourcing Facilities.'' The proposed collections of 
information in the draft guidance are subject to review by OMB under 
the PRA. As required by the PRA, FDA published an analysis of the 
information collection provisions of the draft guidance (79 FR 69857 at 
69858) and intends to submit them for OMB approval.

Recordkeeping

    Entities compounding animal drugs from bulk drug substances should 
keep adequate records to demonstrate that they are compounding such 
drugs in accordance with all of the applicable conditions described in 
the draft guidance. FDA tentatively concludes that it is usual and 
customary for State-licensed pharmacies, veterinarians, and outsourcing 
facilities to keep such records, and that this draft guidance imposes 
no additional recordkeeping burden beyond those usual and customary for 
the respondents to this collection, with the exception of that 
described in section III.A.5. Nonetheless, table 1, row 1 provides a 
nominal estimate of potential recordkeeping burden that respondents may 
incur. FDA therefore specifically invites comment regarding whether 
these provisions impose any effort beyond that which would normally be 
incurred in absence of this draft guidance.
    A condition set forth in section III.A.5. is that, if there is an 
FDA-approved animal or human drug with the same active ingredient(s), 
the pharmacy determines that the compounded drug cannot be made from 
the FDA-approved drug(s), and documents that determination.

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                            Number of       Number of records     Total annual
           Guidance section               recordkeepers     per recordkeeper        records         Average burden per recordkeeping      Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
III; general recordkeeping beyond                 138,551                1               138,551  0.01 (30 seconds)..................              1,386
 usual & customary.
III.A.5; documentation of                          75,000               84.67          6,350,000  0.01 (30 seconds)..................             63,500
 determination that compound drug
 cannot be made from the FDA-approved
 drug(s).
                                       ----------------------------------------------------------                                     ------------------
    Total.............................  .................  ..................  .................  ...................................             64,886
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    For row 1, we base our burden estimates on the American Veterinary 
Medical Association's Market Research Statistics for 2013 for the total 
number of veterinarians in practice minus those veterinarians in food 
animal exclusive practice (63,500), the National Pharmacy Market 
Summary SK&A of March 2010 for the total number of pharmacy sites 
(75,000), and the number of registered outsourcing facilities as of 
March 20, 2015 (51), for a total of 138,551 respondents.\3\
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    \3\ The AVMA's Market Research Statistics--U.S. Veterinarians--
2013 can be found at this URL: (https://www.avma.org/KB/Resources/Statistics/Pages/Market-research-statistics-US-veterinarians.aspx); 
the National Pharmacy Market Summary SK&A (March 2010) can be found 
at this URL: http://www.skainfo.com/index.php; and the list of 
registered outsourcing facilities can be found at this URL: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm378645.htm.
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    For row 2, we estimate that approximately 75,000 pharmacies will 
receive approximately 6,350,000 prescriptions for compounded animal 
drugs annually, and we also estimate that it will take approximately 30 
seconds (0.01 hours) to document that the compounded drug cannot be 
made from the FDA-approved drug(s) for a total of 63,500 hours 
recordkeeping burden.
    A condition set forth in section III.A.2. of the draft guidance is 
that State-licensed pharmacies can compound a drug in advance of 
receipt of a prescription in a quantity that does not exceed the amount 
of drug product that the State-licensed pharmacy compounded pursuant to 
patient-specific prescriptions based on a history of receipt of such 
patient-specific prescriptions for that drug product over any 
consecutive 14-day period within the previous 6 months. The records 
necessary for a State-licensed pharmacy to review to determine that its 
compounding practices are within the condition set forth in section 
III.A.2 of the draft guidance are records that State-licensed 
pharmacies would already be keeping as part of usual and customary 
business practice; therefore, no burden has been estimated for the 
recordkeeping associated with this condition.
    This draft guidance also refers to proposed collections of 
information currently undergoing the process of OMB review under the 
PRA. Recordkeeping by outsourcing facilities, described in the draft 
guidance for industry, ``Current Good Manufacturing Practice--Interim 
Guidance for Human Drug Compounding Outsourcing Facilities Under 
Section 503B of the FD&C Act'' announced July 2, 2014 (79 FR 37743), 
will be reviewed by OMB in response to an information collection 
request associated with that guidance.

Third-Party Disclosure

Prescriptions or Orders for Drugs Compounded From Bulk
    This draft guidance contains new third-party disclosures as 
reported in table 2. Row 1 reflects a potential

[[Page 28628]]

burden associated with section III.C.9. regarding the following 
condition: The veterinarian's prescription or order states, in addition 
to the species, the condition(s) for which the substance is listed in 
Appendix A. At this time, however, FDA has no data upon which to base 
an estimated number of prescriptions or orders to outsourcing 
facilities until the referenced list of bulk drugs (Draft Guidance; 
Appendix A) is finalized. For purposes of this analysis, however, we 
are providing an estimate of 1 as a placeholder.
    In section III.A.4., the draft guidance sets forth the following 
condition: If the drug contains a bulk drug substance that is a 
component of any marketed FDA-approved animal or human drug, there is a 
change between the compounded drug and the comparable FDA-approved 
animal or human drug made for an identified individual patient that 
produces a clinical difference for that identified individual patient, 
as determined by the veterinarian prescribing the compounded drug for 
his/her patient under his/her care. If the drug contains a bulk drug 
substance that is a component of a marketed FDA-approved animal or 
human drug, the prescription or documentation accompanying the 
prescription contains a statement that the change between the 
compounded drug and the FDA-approved drug produces a clinical 
difference for the individual identified patient. For example, the 
veterinarian could state that, ``This compounded drug is needed to 
treat [specifically identified patient] because the approved drug 
product(s) cannot be divided or diluted into the small dose required.''

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of
               Activity                     Number of       disclosures per      Total annual       Average burden per disclosure         Total hours
                                           respondents         respondent        disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
III.C.9; documentation of condition to                  1                  1                  1  0.017 (1 minute)...................               0.017
 be treated.
Statements on prescription (Section                63,500                100          6,350,000  0.017 (1 minute)...................         107,950
 III.A.4 of the draft guidance).
                                       ---------------------------------------------------------                                     -------------------
    Total.............................  .................  .................  .................  ...................................         107,950
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    For row 2, we estimate that approximately 63,500 veterinarians 
will, on average, each produce approximately 100 prescriptions for 
compounded animal drugs annually for a total of 6,350,000 
prescriptions. We also estimate that it will take approximately 1 
minute (0.017 hours) to include the statement discussed in section 
III.A.4 of the draft guidance on each prescription for a total of 
107,950 hours third-party disclosure burden, as reported in table 1.
    It is usual and customary for licensed veterinarians to write 
prescriptions in the normal course of their activities. The conditions 
set forth in the guidance require veterinarians to include certain 
information on prescriptions for animals drugs compounded from bulk 
substances. It is usual and customary for veterinarians to include much 
of this information (except as noted previously); therefore, the time 
it would take to provide this information on prescriptions or documents 
accompanying prescriptions is not included in the burden estimate 
reported in table 2.
    Sections III.A.3 and III.A.6.b of the draft guidance set forth the 
conditions that the following statements appear verbatim on or with 
prescriptions for animal drugs compounded from bulk drug substances:
     ``This patient is not a food-producing animal.'' (Section 
III.A.3).
     ``There are no FDA-approved animal or human drugs that can 
be used as labeled or in an extra-label manner under section 512(a)(4) 
and (5) and 21 CFR part 530 to appropriately treat the disease, 
symptom, or condition for which this drug is being prescribed.'' 
(Section III.A.6.b).
    In addition, section III.C.3 of the draft guidance sets forth the 
condition that the following statement appears verbatim on or with 
prescriptions or orders for animal drugs compounded by outsourcing 
facilities from bulk drug substances listed on Appendix A:
     ``This drug will not be dispensed for or administered to 
food-producing animals.'' (Section III.C.3).
    We tentatively conclude that these statements are ``public 
disclosures of information originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the 
public'' (5 CFR 1320.3(c)(2)) and are therefore not subject to review 
by OMB under the PRA. Thus, the time it would take to provide this 
information is not included in the burden estimate reported in table 2.
Labeling of Drugs Compounded From Bulk Drug Substances
    The draft guidance sets forth conditions for the labeling of animal 
drugs compounded from bulk drug substances. The draft guidance 
indicates in sections III.A.11 and III.B.9 that, to meet the conditions 
of the guidance, State-licensed pharmacies and licensed veterinarians 
include on the label of any compounded drug: The species of the 
intended animal patient, the name of the animal patient, and the name 
of the owner or caretaker of the animal patient. It is usual and 
customary for State-licensed pharmacies and licensed veterinarians to 
include such information on the labels of compounded drugs in the 
normal course of their activities; thus, the time it would take to 
provide this information is not included in the burden estimate 
reported in table 2.
    In addition, the draft guidance indicates in section III.C.10. 
that, to meet the conditions of the guidance, outsourcing facilities 
include on the label of any compounded animal drug pursuant to a 
specific prescription or order: The active ingredient; the dosage form, 
strength, and flavoring, if any; direction for use, as provided by the 
veterinarian prescribing or ordering the drug; the quantity or volume, 
whichever is appropriate; the lot or batch number of the drug; special 
storage and handling instructions; the date the drug was compounded; 
the beyond use date of the drug; the name of the veterinarian 
prescribing or ordering the drug; the inactive ingredients; and the 
address and phone number of the outsourcing facility that compounded 
the drug. It is usual and customary for outsourcing facilities to 
include such information on the labels of compounded drugs in the 
normal course of their activities; thus, the time it would take to 
provide this information is not included in the burden estimate 
reported in table 2.

[[Page 28629]]

    The draft guidance indicates in section III.C.10 that, to meet the 
conditions of the guidance, outsourcing facilities compounding animal 
drug from bulk drug substances for office use in veterinary practices 
include on the label of any compounded drug these four statements:
     ``Not for resale.''
     ``For use only in [fill in species and any associated 
condition or limitation listed in Appendix A].''
     ``Compounded by [name of outsourcing facility].''
     ``Adverse events associated with this compounded drug 
should be reported to FDA on a Form FDA 1932a.''
    We tentatively conclude that these four label statements are 
``public disclosures of information originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the 
public'' (5 CFR 1320.3(c)(2)) and are therefore not subject to review 
by OMB under the PRA. Thus, the time it would take to provide this 
information is not included in the burden estimate reported in table 2.
    This draft guidance also refers to previously approved collections 
of information. A condition set forth in sections III.A.7., III.B.6, 
and III.C.5 is that any bulk drug substance used is manufactured by an 
establishment that is registered under section 510 of the FD&C Act 
(including a foreign establishment that is registered under section 
360(i) of the FD&C Act) and is accompanied by a valid certificate of 
analysis. The information collection related to the disclosure of the 
certificate of analysis is approved under OMB control number 0910-0139.
    Before the proposed information collection provisions contained in 
this draft guidance become effective, we will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the proposed information collection provisions. An Agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number.

VI. Comments

    Interested persons may submit either electronic comments regarding 
this draft guidance to http://www.regulations.gov or written comments 
to the Division of Dockets Management (see ADDRESSES). It is only 
necessary to send one set of comments. Identify comments with Docket 
No. FDA-2015-D-1176. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.

VII. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm042450.htm or 
http://www.regulations.gov.

    Dated: May 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11982 Filed 5-18-15; 8:45 am]
 BILLING CODE 4164-01-P



                                              28624                          Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices

                                              condition(s) in the species that the drug               will receive consideration for later                  10.115(g)(5)), to ensure that FDA
                                              compounded with the nominated                           addition to Appendix A.                               considers your comment on the draft
                                              substance is intended to address;                         Individuals and organization may                    guidance before it begins work on the
                                                 • if there are FDA-approved or index                 petition FDA to make additional                       final version of the guidance, submit
                                              listed drug products that address the                   amendments to Appendix A after it is                  either electronic or written comments
                                              same conditions in the same species, an                 published, in accordance with § 10.30.                on the draft guidance by August 17,
                                              explanation, supported by relevant                        Interested persons may submit either                2015. Submit written or electronic
                                              veterinary literature, of why a                         electronic nominations to http://                     comments on the proposed collection of
                                              compounded drug product is necessary                    www.regulations.gov or written                        information by August 17, 2015.
                                              (i.e., why the approved drug product is                 nominations to the Division of Dockets                ADDRESSES: Submit written requests for
                                              not suitable for a particular patient                   Management (see ADDRESSES). It is only                single copies of the draft guidance to the
                                              population);                                            necessary to send one set of                          Policy and Regulations Staff (HFV–6),
                                                 • a review of the veterinary literature              nominations. Identify nominations with                Center for Veterinary Medicine, Food
                                              to determine whether there are FDA-                     the docket number found in the brackets               and Drug Administration, 7519 Standish
                                              approved animal or human drugs that                     in the heading of this document.                      Pl., Rockville, MD 20855. Send one self-
                                              could be prescribed as an extra-label use               Received nominations may be seen in                   addressed adhesive label to assist that
                                              under section 512(a)(4) and (a)(5) of the               the Division of Dockets Management                    office in processing your request. See
                                              FD&C Act and part 530 to treat the                      between 9 a.m. and 4 p.m., Monday                     the SUPPLEMENTARY INFORMATION section
                                              condition(s) in the species that the drug               through Friday, and will be posted to                 for electronic access to the draft
                                              compounded with the nominated                           the docket at http://                                 guidance.
                                              substance is intended to address;                       www.regulations.gov.                                     Submit electronic comments on the
                                                 • if the bulk drug substance is an                     Dated: May 12, 2015.                                draft guidance, including comments
                                              active ingredient in an approved animal                                                                       regarding the proposed collection of
                                                                                                      Leslie Kux,
                                              or human drug, an explanation,                                                                                information, to http://
                                                                                                      Associate Commissioner for Policy.
                                              supported by appropriate scientific data,                                                                     www.regulations.gov. Submit written
                                                                                                      [FR Doc. 2015–11983 Filed 5–18–15; 8:45 am]
                                              of why the animal drug product cannot                                                                         comments on the draft guidance,
                                              be compounded from the approved drug                    BILLING CODE 4164–01–P
                                                                                                                                                            including comments regarding the
                                              under 21 CFR 530.13(b);                                                                                       proposed collection of information, to
                                                 • an explanation, supported by
                                                                                                      DEPARTMENT OF HEALTH AND                              the Division of Dockets Management
                                              relevant veterinary literature, of why the
                                                                                                      HUMAN SERVICES                                        (HFA–305), Food and Drug
                                              animal drug product to be compounded
                                                                                                                                                            Administration, 5630 Fishers Lane, Rm.
                                              with the nominated bulk drug substance                  Food and Drug Administration                          1061, Rockville, MD 20852.
                                              must be available to the veterinarian for
                                                                                                      [Docket Nos. FDA–2015–D–1176 and FDA–                 FOR FURTHER INFORMATION CONTACT:
                                              immediate treatment to avoid animal
                                              suffering or death. Nominations should                  2003–D–0202]                                          With regard to this draft guidance:
                                              include specific information                                                                                  Division of Compliance, Center for
                                                                                                      Compounding Animal Drugs From                         Veterinary Medicine, Food and Drug
                                              documenting that animal suffering or
                                                                                                      Bulk Drug Substances; Draft Guidance                  Administration (HFV–230), 7519
                                              death will result if treatment is delayed
                                                                                                      for Industry; Availability; Withdrawal of             Standish Pl., Rockville, MD 20855, 240–
                                              until a compounded animal drug can be
                                                                                                      Compliance Policy Guide; Section                      402–7001, CVMCompliance@
                                              obtained pursuant to a prescription for                 608.400 Compounding of Drugs for
                                              an individually identified animal; and                                                                        fda.hhs.gov.
                                                                                                      Use in Animals                                           With regard to the proposed collection
                                                 • a discussion of any safety concerns
                                              associated with use of the nominated                                                                          of information: FDA PRA Staff, Office of
                                                                                                      AGENCY:    Food and Drug Administration,
                                              bulk drug substance or finished                         HHS.                                                  Operations, Food and Drug
                                              compounded product for the                                                                                    Administration, 8455 Colesville Rd.;
                                                                                                      ACTION:   Notice; withdrawal.                         COLE–14526, Silver Spring, MD 20993–
                                              condition(s) in the species that the
                                              compounded drug is intended to                          SUMMARY:   The Food and Drug                          0002; PRAStaff@fda.hhs.gov.
                                              address. If there are any safety concerns,              Administration (FDA) is announcing the                SUPPLEMENTARY INFORMATION:
                                              an explanation, supported by veterinary                 availability of a draft guidance for                  I. Draft Guidance
                                              literature, of why the concerns should                  industry (GFI) #230 entitled
                                                                                                      ‘‘Compounding Animal Drugs from Bulk                     FDA is announcing the availability of
                                              not preclude inclusion of that bulk drug
                                                                                                      Drug Substances.’’ The draft guidance                 a draft GFI #230 entitled ‘‘Compounding
                                              substance on Appendix A.
                                                                                                      describes FDA’s policies with regard to               Animal Drugs from Bulk Drug
                                              D. Nomination Process                                   compounding animal drugs from bulk                    Substances.’’ The draft guidance
                                                 For efficient consolidation and review               drug substances. When final, the                      provides information to compounders of
                                              of nominations, nominators are                          guidance will reflect FDA’s current                   animal drugs and other interested
                                              encouraged to submit their nominations                  thinking on the issues addressed by the               stakeholders on FDA’s application of
                                              in a format that explicitly addresses                   guidance.                                             the Federal Food, Drug, and Cosmetic
                                              each item previously listed in the order                   FDA is also announcing the                         Act (the FD&C Act) with respect to the
                                              that they appear. To consider a bulk                    withdrawal of the compliance policy                   compounding of animal drugs from bulk
                                              drug substance for inclusion in                         guide (CPG) entitled ‘‘Section 608.400                drug substances.1
                                              Appendix A, FDA must receive                            Compounding of Drugs for Use in
                                                                                                                                                              1 FDA regulations define ‘‘bulk drug substance’’
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                                              adequate supporting data for the                        Animals,’’ which was issued in July
                                                                                                                                                            as ‘‘any substance that is represented for use in a
                                              substance. FDA cannot guarantee that                    2003. This 2003 CPG is being                          drug and that, when used in the manufacturing,
                                              all drugs nominated during the                          withdrawn because it is no longer                     processing, or packaging of a drug, becomes an
                                              nomination period will be considered                    consistent with FDA’s current thinking                active ingredient or a finished dosage form of the
                                                                                                      on the issues it addresses.                           drug, but the term does not include intermediates
                                              for inclusion on Appendix A prior to its                                                                      used in the synthesis of such substances.’’ 21 CFR
                                              initial publication. Nominations that are               DATES: Although you can comment on                    207.3(a)(4). ‘‘Active ingredient’’ is defined as ‘‘any
                                              not evaluated during this first phase                   any guidance at any time (see 21 CFR                  component that is intended to furnish



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                                                                               Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices                                                  28625

                                                 Sections 503A (21 U.S.C. 353a) and                    that FDA does not generally intend to                Outsourcing Facility to Compound
                                              503B (21 U.S.C. 353b) of the FD&C Act                    take action under sections 512(a),                   Drugs for Use in Animals.’’ The notice
                                              do not apply to the compounding of                       501(a)(5) (21 U.S.C. 351(a)(5)),                     also describes the information that
                                              animal drugs. The FD&C Act does not                      501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)), and           should be provided to the Agency in
                                              distinguish between compounding                          502(f)(1) of the FD&C Act if a State-                support of such nominations.
                                              animal drugs from bulk drug substances                   licensed pharmacy or a licensed
                                                                                                                                                            II. Withdrawal of 2003 Compliance
                                              and any other manufacturing or                           veterinarian compounds drugs intended
                                                                                                                                                            Policy Guide
                                              processing of animal drugs. Except with                  for use in animals from bulk drug
                                              respect to the limited exemption                         substances in accordance with all of the                In a notice published in the Federal
                                              provided by the FD&C Act described in                    applicable conditions set out in the                 Register of July 14, 2003 (68 FR 41591),
                                              this document, statutory provisions                      guidance. In addition, the draft                     FDA announced the availability of CPG
                                              applicable to manufactured animal                        guidance provides that FDA does not                  Section 608.400 of the Compliance
                                              drugs under the FD&C Act also apply to                   generally intend to take action under                Program Guidance Manual entitled,
                                              compounded animal drugs.                                 sections 512(a), 501(a)(5), and 502(f)(1)            ‘‘Compounding of Drugs for Use in
                                                 Section 512(a)(4) and (5) of the FD&C                 of the FD&C Act if the drug product is               Animals.’’ This document is being
                                              Act (21 U.S.C. 360b(a)(4) and (5)),                      compounded from a bulk drug                          withdrawn because it is no longer
                                              provide a limited exemption from                         substance by an outsourcing facility and             consistent with FDA’s current thinking
                                              certain requirements for use for                         that meets all of the applicable                     on the issue it addresses. The current
                                              compounded animal drugs made from                        conditions set out in the guidance, and              CPG does not focus on the three main
                                              already approved animal or human                         the drug product is compounded from a                concerns FDA has about animal drug
                                              drugs. Such use is considered an extra-                  bulk drug substance that appears on                  compounding: compounding copies of
                                              label use and the FD&C Act provides                      Appendix A of the draft guidance.                    approved animal or human drugs from
                                              that a compounded drug is exempt from                       Importantly, the draft guidance                   bulk drug substances, compounding for
                                              the approval requirements and                            provides that FDA generally intends to               food-producing animals from bulk drug
                                              requirements of section 502(f)(1) (21                    enforce all other adulteration and                   substances, and compounding office
                                              U.S.C. 352(f)(1)) of the FD&C Act, if it                 misbranding provisions of the FD&C Act               stock from bulk drug substances.
                                              meets the conditions set out in the                      against entities compounding animal                  Because the CPG does not reflect FDA’s
                                              statute and the extra-label use                          drugs from bulk drug substances.                     current thinking, to leave it in effect
                                              regulations at 21 CFR part 530.                             To ensure FDA can timely identify                 until this draft guidance is finalized
                                                 This draft guidance does not address                  and address safety issues related to                 may confuse stakeholders about FDA’s
                                              the compounding of animal drugs from                     animal drugs compounded from bulk                    current enforcement priorities.
                                              approved animal or human drugs                           drug substances, one of the conditions,              Stakeholders should be aware that, until
                                              pursuant to the extra-label provisions of                if met, under which FDA does not                     this draft guidance is finalized, FDA
                                              the law, nor does it address the                         generally intend to take action for                  intends to look at the totality of the
                                              repackaging of approved animal drugs.                    violations of the provisions described               circumstances when determining
                                              FDA is considering whether guidance is                   previously is that State-licensed                    whether to take enforcement action for
                                              needed on those issues, and if so, will                  pharmacies and veterinarians report any              unlawful animal drug compounding
                                              publish separate guidances. In section                   product defect or serious adverse event              activities.
                                              III, FDA is asking for comment on                        associated with animal drugs they
                                                                                                       compound from a bulk drug substance                  III. Specific Topics for Comment
                                              specific questions about several issues
                                              including the practice of compounding                    to FDA, within 15 days of becoming                      In addition to comments on the draft
                                                                                                       aware of them, using Form FDA 1932a.                 guidance as written, we are specifically
                                              from approved animal and human drugs
                                                                                                       FDA intends to use these adverse event               requesting comments on the following
                                              and the repackaging of drugs for animal
                                                                                                       reports to identify animal drugs                     issues:
                                              use to help determine whether
                                                                                                       compounded from bulk drug substances                    • Should the final guidance address
                                              additional guidance is necessary on
                                                                                                       that present serious risks to animal                 the issue of FDA-approved animal and
                                              these topics.
                                                                                                       health. Unlike for human drugs, there                human drugs that are in shortage or are
                                                 This draft guidance describes
                                                                                                       are no State Departments of Health or                otherwise unavailable (e.g., disruptions
                                              conditions under which FDA does not
                                                                                                       Federal Agencies, such as the Centers                in the manufacture or supply chain;
                                              generally intend to initiate enforcement
                                                                                                       for Disease Control and Prevention                   business decisions to stop marketing the
                                              action against State-licensed
                                                                                                       (CDC), which are responsible for                     drug; drug is subject to Agency action
                                              pharmacies, licensed veterinarians, and
                                                                                                       identifying and tracing the source of                based on safety, effectiveness, or
                                              facilities registered as outsourcing
                                                                                                       injury and/or disease in animals.                    manufacturing concerns)? If so:
                                              facilities under section 503B of the
                                                                                                       Adverse event reporting regarding drugs                 Æ How should these situations be
                                              FD&C Act (outsourcing facilities) that
                                                                                                       compounded from bulk drug substances                 addressed in the final guidance?
                                              compound animal drugs from bulk drug                                                                             Æ How should the final guidance
                                                                                                       by compounding pharmacies and
                                              substances. The draft guidance provides                                                                       define the terms ‘‘shortage’’ and
                                                                                                       veterinarians will provide a mechanism
                                                                                                       for FDA to identify and possibly prevent             ‘‘unavailable’’?
                                              pharmacological activity or other direct effect in the
                                              diagnosis, cure, mitigation, treatment, or prevention    adverse events associated with                          Æ What criteria should FDA use to
                                              of disease, or to affect the structure or any function   compounded animal drugs. This is                     determine if an approved animal or
                                              of the body of man or other animals. The term            another topic on which we are                        human drug is in shortage or otherwise
                                              includes those components that may undergo               requesting specific comment in section               unavailable?
                                              chemical change in the manufacture of the drug                                                                   • Do United States Pharmacopeia and
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                                              product and be present in the drug product in a          III.
                                              modified form intended to furnish the specified             Elsewhere in this issue of the Federal            National Formulary (USP–NF) 2
                                              activity or effect.’’ 21 CFR 210.3(b)(7). Any            Register, FDA is publishing a notice
                                              component other than an active ingredient is an          soliciting nominations for bulk drug                   2 Chapters <795> ‘‘Pharmaceutical

                                              ‘‘inactive ingredient.’’ See 21 CFR 210.3(b)(8).                                                              Compounding—Nonsterile Preparations’’ and
                                              Inactive ingredients used in compounded drug
                                                                                                       substances that should be included in                <797> ‘‘Pharmaceutical Compounding—Sterile
                                              products commonly include flavorings, dyes,              Appendix A, ‘‘List of Bulk Drug                      Preparations’’ can be found in the combined United
                                              diluents, or other excipients.                           Substances That May Be Used By an                                                             Continued




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                                              28626                          Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices

                                              chapters <795> and <797> provide                        facilities are required to report adverse             public submit reports, keep records, or
                                              suitable standards for animal drugs                     events associated with the drugs they                 provide information to a third party.
                                              compounded by veterinarians, and if                     compound. FDA believes it is important                Section 3506(c)(2)(A) of the PRA, 44
                                              not, what standards of safety, purity,                  to receive this information from State-               U.S.C. 3506(c)(2)(A), requires Federal
                                              and quality should apply to animal                      licensed pharmacies and veterinarians                 Agencies to provide a 60-day notice in
                                              drugs compounded by veterinarians?                      because there are no other State                      the Federal Register for each proposed
                                                 • Should licensed veterinarians be                   Departments of Health or Federal                      collection of information before
                                              able to sell or transfer an animal drug                 Agencies (e.g., the CDC) charged with                 submitting the collection to OMB for
                                              compounded from bulk drug substances                    identifying and tracing animal injuries               approval. To comply with this
                                              by a State-licensed pharmacy or an                      or disease associated with an animal                  requirement, FDA is publishing this
                                              outsourcing facility to owners or                       drug compounded by these entities.                    notice of the proposed collection of
                                              caretakers of animals under the                         FDA has the following specific                        information set forth in this document.
                                              veterinarian’s care?                                    questions with respect to this proposed                  With respect to the collection of
                                                 • How should FDA apply the                           condition:                                            information associated with this draft
                                              condition to identify an individual                        Æ How many State-licensed                          guidance, we invite comments on these
                                              patient when it is not possible to                      pharmacies and veterinarians                          topics: (1) Whether the proposed
                                              identify an individual animal (e.g., koi                compound animal drugs from bulk drug                  collection of information is necessary
                                              in a koi pond)?                                         substances and would potentially be                   for the proper performance of FDA’s
                                                 • Should the final guidance include a                reporting product defects and serious                 functions, including whether the
                                              condition on the amount or percentage                   adverse events to FDA?                                information will have practical utility;
                                              of compounded animal drugs that a                          Æ Are State-licensed pharmacies and                (2) the accuracy of FDA’s estimate of the
                                              pharmacy or outsourcing facility can                    veterinarians reporting the same or                   burden of the proposed collection of
                                              ship in interstate commerce? If so, what                similar information to any State                      information, including the validity of
                                              would a reasonable amount be?                           regulatory agency (e.g., State boards of              the methodology and assumptions used;
                                                 • Should facilities registered as                    pharmacy, State boards of veterinary                  (3) ways to enhance the quality, utility,
                                              outsourcing facilities under section                    medicine)? If so, how many reports on                 and clarity of the information to be
                                              503B of the FD&C Act be able to                         average does each State-licensed                      collected; and (4) ways to minimize the
                                              compound animal drugs from bulk drug                    pharmacy and veterinarian submit to                   burden of the collection of information
                                              substances that do not appear on                        these State agencies each year?                       on respondents, including through the
                                              Appendix A for an individually                             Æ For purposes of the guidance, how                use of automated collection techniques,
                                              identified animal patient under                         should FDA define the terms ‘‘product                 when appropriate, and other forms of
                                              conditions similar to those applicable to               defect’’ and ‘‘serious adverse event’’?               information technology.
                                              state-licensed pharmacies (i.e., the                       Æ Can FDA achieve the same                            Title: Compounding Animal Drugs
                                              conditions contained in section III.A. of               objective of identifying and tracing the              from Bulk Drug Substances (OMB
                                              the draft guidance)?                                    source of injuries or disease associated              Control Number 0910–NEW)
                                                 • Is additional guidance needed to                   with an animal drug compounded from                      Description of Respondents: The
                                              address the repackaging of drugs for                    a bulk drug substance through means                   proposed collection of information
                                              animal use?                                             other than product defect and serious                 would affect State-licensed pharmacies,
                                                 Æ How widespread is the practice of                  adverse event reporting, and if so, what              licensed veterinarians, and outsourcing
                                              repackaging drugs for animal use?                       other means? For example, would                       facilities that compound animal drugs
                                                 Æ What types of drugs are repackaged                 reports of product defects alone achieve              from bulk drug substances.
                                              for animal use, and why are they                        the same objective?                                      Description: This draft guidance
                                              repackaged?                                                                                                   describes FDA’s current thinking
                                                                                                      IV. Significance of Guidance                          regarding compounding animal drugs
                                                 Æ Have problems been identified with
                                              repackaged drugs for animal use?                           This Level 1 draft guidance is being               from bulk drug substances and describes
                                                 • Is additional guidance needed to                   issued consistent with FDA’s good                     the conditions under which FDA does
                                              address the compounding of animal                       guidance practices regulation (21 CFR                 not generally intend to take action for
                                              drugs from approved animal or human                     10.115). The draft guidance, when                     violations of the following sections of
                                              drugs under section 512(a)(4) or (a)(5) of              finalized, will represent the current                 the FD&C Act: 512, 501(a)(5), 502(f)(1),
                                              the FD&C Act and part 530?                              thinking of FDA on compounding                        and, where specified, 501(a)(2)(B), when
                                                 • Is additional guidance needed to                   animal drugs from bulk drug substances.               a State-licensed pharmacy, licensed
                                              address the compounding of animal                       It does not establish any rights for any              veterinarian, or an outsourcing facility
                                              drugs from bulk drug substances for                     person and is not binding on FDA or the               compounds animal drugs from bulk
                                              food-producing animals?                                 public. You can use an alternative                    drug substances. The draft guidance
                                                 • As one condition under which FDA                   approach if it satisfies the requirements             provides three sets of conditions, one
                                              does not generally intend to take action                of the applicable statutes and                        for each entity: State-licensed
                                              for certain violations of the FD&C Act if               regulations.                                          pharmacies, licensed veterinarians, and
                                              this and the other conditions are                                                                             outsourcing facilities.
                                                                                                      V. Paperwork Reduction Act of 1995                       This draft guidance only addresses
                                              followed, FDA is proposing that State-
                                              licensed pharmacies and veterinarians                      This draft guidance contains proposed              the compounding of animal drugs from
                                              report any product defect or serious                    information collection provisions that                bulk drug substances. It does not apply
                                              adverse event associated with animal                    are subject to review by the Office of                to the compounding of animal drugs
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                                              drugs they compound from bulk drug                      Management and Budget (OMB) under                     from approved new animal or new
                                              substances to FDA within 15 days of                     the Paperwork Reduction Act of 1995                   human drugs. Such compounding can
                                              becoming aware of the product defect or                 (the PRA) (44 U.S.C. 3501–3520).                      be conducted in accordance with the
                                              serious adverse event. Outsourcing                      ‘‘Collection of information’’ is defined              provisions of section 512(a)(4) and (5) of
                                                                                                      in 44 U.S.C. 3502(3) and 5 CFR                        the FD&C Act and part 530. In addition,
                                              States Pharmacopeia and National Formulary              1320.3(c) and includes Agency requests                this guidance does not address the
                                              (USP–NF), available at http://www.usp.org/.             or requirements that members of the                   compounding of drugs intended for use


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                                                                                       Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices                                                                                           28627

                                              in humans, which is addressed in other                                  refers to proposed collections of                                             that it is usual and customary for State-
                                              guidances.                                                              information regarding drugs made by an                                        licensed pharmacies, veterinarians, and
                                                FDA estimates the burden of this                                      outsourcing facility during the previous                                      outsourcing facilities to keep such
                                              collection of information as follows:                                   6-month period as described in FDA’s                                          records, and that this draft guidance
                                                                                                                      notice of November 24, 2014 (79 FR                                            imposes no additional recordkeeping
                                              Reporting                                                               69857), announcing the availability of a                                      burden beyond those usual and
                                                This draft guidance contains no new                                   draft guidance entitled ‘‘Electronic                                          customary for the respondents to this
                                              reporting provisions. This draft                                        Reporting for Human Drug                                                      collection, with the exception of that
                                              guidance refers to previously approved                                  Compounding Outsourcing Facilities.’’                                         described in section III.A.5.
                                              collections of information found in FDA                                 The proposed collections of information                                       Nonetheless, table 1, row 1 provides a
                                              regulations. These collections of                                       in the draft guidance are subject to                                          nominal estimate of potential
                                              information are subject to review by                                    review by OMB under the PRA. As                                               recordkeeping burden that respondents
                                              OMB under the PRA. The collections of                                   required by the PRA, FDA published an                                         may incur. FDA therefore specifically
                                              information regarding voluntary                                         analysis of the information collection                                        invites comment regarding whether
                                              reporting of adverse drug experiences or                                provisions of the draft guidance (79 FR                                       these provisions impose any effort
                                              product/manufacturing defects on Form                                   69857 at 69858) and intends to submit                                         beyond that which would normally be
                                              FDA 1932a, ‘‘Veterinary Adverse Drug                                    them for OMB approval.                                                        incurred in absence of this draft
                                              Reaction, Lack of Effectiveness or                                                                                                                    guidance.
                                                                                                                      Recordkeeping
                                              Product Defect Report,’’ have been                                                                                                                       A condition set forth in section
                                              approved under OMB control number                                         Entities compounding animal drugs                                           III.A.5. is that, if there is an FDA-
                                              0910–0284; the information collection                                   from bulk drug substances should keep                                         approved animal or human drug with
                                              provisions regarding establishment                                      adequate records to demonstrate that                                          the same active ingredient(s), the
                                              registration under section 510 of the                                   they are compounding such drugs in                                            pharmacy determines that the
                                              FD&C Act (21 U.S.C. 360) have been                                      accordance with all of the applicable                                         compounded drug cannot be made from
                                              approved under OMB control number                                       conditions described in the draft                                             the FDA-approved drug(s), and
                                              0910–0777. This draft guidance also                                     guidance. FDA tentatively concludes                                           documents that determination.

                                                                                                    TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
                                                                                                         Number of                   Number of records                      Total annual                  Average burden per
                                                         Guidance section                                                                                                                                                                       Total hours
                                                                                                       recordkeepers                 per recordkeeper                         records                       recordkeeping

                                              III; general recordkeeping beyond                                     138,551                                   1                         138,551          0.01 (30 seconds) .....                         1,386
                                                  usual & customary.
                                              III.A.5; documentation of deter-                                         75,000                               84.67                     6,350,000          0.01 (30 seconds) .....                       63,500
                                                  mination that compound drug
                                                  cannot be made from the FDA-
                                                  approved drug(s).

                                                   Total ........................................   ..............................   ................................   ..............................   ....................................          64,886
                                                 1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                 For row 1, we base our burden                                        drugs annually, and we also estimate                                          keeping as part of usual and customary
                                              estimates on the American Veterinary                                    that it will take approximately 30                                            business practice; therefore, no burden
                                              Medical Association’s Market Research                                   seconds (0.01 hours) to document that                                         has been estimated for the
                                              Statistics for 2013 for the total number                                the compounded drug cannot be made                                            recordkeeping associated with this
                                              of veterinarians in practice minus those                                from the FDA-approved drug(s) for a                                           condition.
                                              veterinarians in food animal exclusive                                  total of 63,500 hours recordkeeping                                             This draft guidance also refers to
                                              practice (63,500), the National                                         burden.                                                                       proposed collections of information
                                              Pharmacy Market Summary SK&A of                                            A condition set forth in section                                           currently undergoing the process of
                                              March 2010 for the total number of                                                                                                                    OMB review under the PRA.
                                                                                                                      III.A.2. of the draft guidance is that
                                              pharmacy sites (75,000), and the                                                                                                                      Recordkeeping by outsourcing facilities,
                                                                                                                      State-licensed pharmacies can
                                              number of registered outsourcing                                                                                                                      described in the draft guidance for
                                                                                                                      compound a drug in advance of receipt
                                              facilities as of March 20, 2015 (51), for                                                                                                             industry, ‘‘Current Good Manufacturing
                                                                                                                      of a prescription in a quantity that does
                                              a total of 138,551 respondents.3                                                                                                                      Practice—Interim Guidance for Human
                                                 For row 2, we estimate that                                          not exceed the amount of drug product
                                                                                                                      that the State-licensed pharmacy                                              Drug Compounding Outsourcing
                                              approximately 75,000 pharmacies will                                                                                                                  Facilities Under Section 503B of the
                                              receive approximately 6,350,000                                         compounded pursuant to patient-
                                                                                                                      specific prescriptions based on a history                                     FD&C Act’’ announced July 2, 2014 (79
                                              prescriptions for compounded animal                                                                                                                   FR 37743), will be reviewed by OMB in
                                                                                                                      of receipt of such patient-specific
                                                                                                                      prescriptions for that drug product over                                      response to an information collection
                                                 3 The AVMA’s Market Research Statistics—U.S.

                                              Veterinarians—2013 can be found at this URL:                            any consecutive 14-day period within                                          request associated with that guidance.
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                                              (https://www.avma.org/KB/Resources/Statistics/                          the previous 6 months. The records                                            Third-Party Disclosure
                                              Pages/Market-research-statistics-US-
                                              veterinarians.aspx); the National Pharmacy Market                       necessary for a State-licensed pharmacy
                                                                                                                                                                                                    Prescriptions or Orders for Drugs
                                              Summary SK&A (March 2010) can be found at this                          to review to determine that its
                                                                                                                                                                                                    Compounded From Bulk
                                              URL: http://www.skainfo.com/index.php; and the                          compounding practices are within the
                                              list of registered outsourcing facilities can be found                  condition set forth in section III.A.2 of                                       This draft guidance contains new
                                              at this URL: http://www.fda.gov/Drugs/
                                              GuidanceComplianceRegulatoryInformation/                                the draft guidance are records that State-                                    third-party disclosures as reported in
                                              PharmacyCompounding/ucm378645.htm.                                      licensed pharmacies would already be                                          table 2. Row 1 reflects a potential


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                                              28628                                    Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices

                                              burden associated with section III.C.9.                                    In section III.A.4., the draft guidance                                       is a component of a marketed FDA-
                                              regarding the following condition: The                                  sets forth the following condition: If the                                       approved animal or human drug, the
                                              veterinarian’s prescription or order                                    drug contains a bulk drug substance that                                         prescription or documentation
                                              states, in addition to the species, the                                 is a component of any marketed FDA-                                              accompanying the prescription contains
                                              condition(s) for which the substance is                                 approved animal or human drug, there                                             a statement that the change between the
                                              listed in Appendix A. At this time,                                     is a change between the compounded                                               compounded drug and the FDA-
                                              however, FDA has no data upon which                                     drug and the comparable FDA-approved                                             approved drug produces a clinical
                                              to base an estimated number of                                          animal or human drug made for an                                                 difference for the individual identified
                                              prescriptions or orders to outsourcing                                  identified individual patient that                                               patient. For example, the veterinarian
                                              facilities until the referenced list of bulk                            produces a clinical difference for that
                                                                                                                                                                                                       could state that, ‘‘This compounded
                                                                                                                      identified individual patient, as
                                              drugs (Draft Guidance; Appendix A) is                                                                                                                    drug is needed to treat [specifically
                                                                                                                      determined by the veterinarian
                                              finalized. For purposes of this analysis,                                                                                                                identified patient] because the approved
                                                                                                                      prescribing the compounded drug for
                                              however, we are providing an estimate                                   his/her patient under his/her care. If the                                       drug product(s) cannot be divided or
                                              of 1 as a placeholder.                                                  drug contains a bulk drug substance that                                         diluted into the small dose required.’’

                                                                                            TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
                                                                                                                                          Number of
                                                                                                         Number of                                                        Total annual                   Average burden per
                                                                 Activity                                                              disclosures per                                                                                         Total hours
                                                                                                        respondents                                                       disclosures                        disclosure
                                                                                                                                         respondent

                                              III.C.9; documentation of condition                                               1                                1                               1      0.017 (1 minute) ........                       0.017
                                                  to be treated.
                                              Statements on prescription (Sec-                                         63,500                                100                    6,350,000           0.017 (1 minute) ........                 107,950
                                                  tion III.A.4 of the draft guidance).

                                                   Total ........................................   ..............................   ..............................   ..............................    ....................................      107,950
                                                 1 There   are no capital costs or operating and maintenance costs associated with this collection of information.


                                                 For row 2, we estimate that                                          as labeled or in an extra-label manner                                           intended animal patient, the name of
                                              approximately 63,500 veterinarians will,                                under section 512(a)(4) and (5) and 21                                           the animal patient, and the name of the
                                              on average, each produce approximately                                  CFR part 530 to appropriately treat the                                          owner or caretaker of the animal patient.
                                              100 prescriptions for compounded                                        disease, symptom, or condition for                                               It is usual and customary for State-
                                              animal drugs annually for a total of                                    which this drug is being prescribed.’’                                           licensed pharmacies and licensed
                                              6,350,000 prescriptions. We also                                        (Section III.A.6.b).                                                             veterinarians to include such
                                              estimate that it will take approximately                                   In addition, section III.C.3 of the draft                                     information on the labels of
                                              1 minute (0.017 hours) to include the                                   guidance sets forth the condition that                                           compounded drugs in the normal course
                                              statement discussed in section III.A.4 of                               the following statement appears                                                  of their activities; thus, the time it
                                              the draft guidance on each prescription                                 verbatim on or with prescriptions or                                             would take to provide this information
                                              for a total of 107,950 hours third-party                                orders for animal drugs compounded by                                            is not included in the burden estimate
                                              disclosure burden, as reported in table                                 outsourcing facilities from bulk drug                                            reported in table 2.
                                              1.                                                                      substances listed on Appendix A:                                                    In addition, the draft guidance
                                                 It is usual and customary for licensed                                  • ‘‘This drug will not be dispensed                                           indicates in section III.C.10. that, to
                                              veterinarians to write prescriptions in                                 for or administered to food-producing                                            meet the conditions of the guidance,
                                              the normal course of their activities. The                              animals.’’ (Section III.C.3).                                                    outsourcing facilities include on the
                                              conditions set forth in the guidance                                       We tentatively conclude that these                                            label of any compounded animal drug
                                              require veterinarians to include certain                                statements are ‘‘public disclosures of                                           pursuant to a specific prescription or
                                              information on prescriptions for animals                                information originally supplied by the                                           order: The active ingredient; the dosage
                                              drugs compounded from bulk                                              Federal Government to the recipient for                                          form, strength, and flavoring, if any;
                                              substances. It is usual and customary for                               the purpose of disclosure to the public’’                                        direction for use, as provided by the
                                              veterinarians to include much of this                                   (5 CFR 1320.3(c)(2)) and are therefore                                           veterinarian prescribing or ordering the
                                              information (except as noted                                            not subject to review by OMB under the                                           drug; the quantity or volume, whichever
                                              previously); therefore, the time it would                               PRA. Thus, the time it would take to                                             is appropriate; the lot or batch number
                                              take to provide this information on                                     provide this information is not included                                         of the drug; special storage and handling
                                              prescriptions or documents                                              in the burden estimate reported in table                                         instructions; the date the drug was
                                              accompanying prescriptions is not                                       2.                                                                               compounded; the beyond use date of the
                                              included in the burden estimate                                                                                                                          drug; the name of the veterinarian
                                                                                                                      Labeling of Drugs Compounded From                                                prescribing or ordering the drug; the
                                              reported in table 2.                                                    Bulk Drug Substances
                                                 Sections III.A.3 and III.A.6.b of the                                                                                                                 inactive ingredients; and the address
                                              draft guidance set forth the conditions                                   The draft guidance sets forth                                                  and phone number of the outsourcing
                                              that the following statements appear                                    conditions for the labeling of animal                                            facility that compounded the drug. It is
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                                              verbatim on or with prescriptions for                                   drugs compounded from bulk drug                                                  usual and customary for outsourcing
                                              animal drugs compounded from bulk                                       substances. The draft guidance indicates                                         facilities to include such information on
                                              drug substances:                                                        in sections III.A.11 and III.B.9 that, to                                        the labels of compounded drugs in the
                                                 • ‘‘This patient is not a food-                                      meet the conditions of the guidance,                                             normal course of their activities; thus,
                                              producing animal.’’ (Section III.A.3).                                  State-licensed pharmacies and licensed                                           the time it would take to provide this
                                                 • ‘‘There are no FDA-approved                                        veterinarians include on the label of any                                        information is not included in the
                                              animal or human drugs that can be used                                  compounded drug: The species of the                                              burden estimate reported in table 2.


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                                                                             Federal Register / Vol. 80, No. 96 / Tuesday, May 19, 2015 / Notices                                                   28629

                                                 The draft guidance indicates in                      through Friday, and will be posted to                    Background on the Review Committee,
                                              section III.C.10 that, to meet the                      the docket at http://                                 including the Review Committee’s Charter
                                              conditions of the guidance, outsourcing                 www.regulations.gov.                                  can be accessed at http://www.ncvhs.hhs.gov/
                                              facilities compounding animal drug                                                                            subcommittees-work-groups/subcommittee-
                                                                                                      VII. Electronic Access                                on-standards/review-committee/.
                                              from bulk drug substances for office use                                                                         Contact Person for More Information:
                                              in veterinary practices include on the                    Persons with access to the Internet
                                                                                                                                                            Debbie M. Jackson, Acting Executive
                                              label of any compounded drug these                      may obtain the draft guidance at either               Secretary, NCVHS, National Center for
                                              four statements:                                        http://www.fda.gov/AnimalVeterinary/                  Health Statistics, Centers for Disease Control
                                                 • ‘‘Not for resale.’’                                GuidanceComplianceEnforcement/                        and Prevention, 3311 Toledo Road, Room
                                                 • ‘‘For use only in [fill in species and             GuidanceforIndustry/ucm042450.htm or                  2339, Hyattsville, Maryland 20782, telephone
                                              any associated condition or limitation                  http://www.regulations.gov.                           (301) 458–4614 or Terri Deutsch, Centers for
                                              listed in Appendix A].’’                                                                                      Medicare and Medicaid Services, Office of E-
                                                                                                        Dated: May 12, 2015.
                                                 • ‘‘Compounded by [name of                                                                                 Health Standards and Services, 7500 Security
                                                                                                      Leslie Kux,                                           Boulevard, Baltimore, Maryland 21244,
                                              outsourcing facility].’’
                                                 • ‘‘Adverse events associated with                   Associate Commissioner for Policy.                    telephone (410) 786–9462. Program
                                              this compounded drug should be                          [FR Doc. 2015–11982 Filed 5–18–15; 8:45 am]           information as well as summaries of meetings
                                                                                                                                                            and a roster of committee members are
                                              reported to FDA on a Form FDA 1932a.’’                  BILLING CODE 4164–01–P
                                                                                                                                                            available on the NCVHS home page of the
                                                 We tentatively conclude that these                                                                         HHS Web site:
                                              four label statements are ‘‘public                                                                            http://ncvhs.us/, where further information
                                              disclosures of information originally                   DEPARTMENT OF HEALTH AND
                                                                                                                                                            including an agenda will be posted when
                                              supplied by the Federal Government to                   HUMAN SERVICES                                        available.
                                              the recipient for the purpose of                                                                                 Should you require reasonable
                                                                                                      National Committee on Vital and Health
                                              disclosure to the public’’ (5 CFR                                                                             accommodation, please contact the CDC
                                                                                                      Statistics: Meeting                                   Office of Equal Employment Opportunity on
                                              1320.3(c)(2)) and are therefore not
                                              subject to review by OMB under the                        Pursuant to the Federal Advisory                    (301) 458–4EEO (4336) as soon as possible.
                                              PRA. Thus, the time it would take to                    Committee Act, the Department of                         Dated: May 13, 2015.
                                              provide this information is not included                Health and Human Services (HHS)                       James Scanlon,
                                              in the burden estimate reported in table                announces the following advisory                      Deputy Assistant Secretary for Planning and
                                              2.                                                      committee meeting.                                    Evaluation Science and Data Policy, Office
                                                 This draft guidance also refers to                      Name: National Committee on Vital and              of the Assistant Secretary for Planning and
                                              previously approved collections of                      Health Statistics (NCVHS) Review                      Evaluation.
                                              information. A condition set forth in                   Committee, pursuant to Section 1104(i) of the         [FR Doc. 2015–12106 Filed 5–18–15; 8:45 am]
                                              sections III.A.7., III.B.6, and III.C.5 is              Patient Protection and Affordable Care Act            BILLING CODE 4151–05–P
                                              that any bulk drug substance used is                    (ACA).
                                              manufactured by an establishment that                      Time and Date: June 16, 2015, 9:00 a.m.–
                                              is registered under section 510 of the                  5:00 p.m. EST; June 17, 2015, 8:00 a.m.–5:15          DEPARTMENT OF HEALTH AND
                                              FD&C Act (including a foreign                           p.m. EST.
                                                                                                                                                            HUMAN SERVICES
                                                                                                         Place: U.S. Department of Health and
                                              establishment that is registered under                  Human Services, Centers for Disease Control
                                              section 360(i) of the FD&C Act) and is                                                                        Meetings of the Advisory Group on
                                                                                                      and Prevention, National Center for Health
                                              accompanied by a valid certificate of                   Statistics, 3311 Toledo Road, Auditorium B            Prevention, Health Promotion, and
                                              analysis. The information collection                    and C, Hyattsville, Maryland 20782, (301)             Integrative and Public Health
                                              related to the disclosure of the                        458–4524.
                                                                                                         Status: Open.                                      AGENCY:  Office of the Surgeon General
                                              certificate of analysis is approved under
                                                                                                         Purpose: The purpose of this hearing is to         of the United States Public Health
                                              OMB control number 0910–0139.
                                                 Before the proposed information                      obtain information from the health care               Service, Office of the Assistant Secretary
                                              collection provisions contained in this                 industry on the currently adopted standards,          for Health, Office of the Secretary,
                                              draft guidance become effective, we will
                                                                                                      operating rules, code sets and identifiers            Department of Health and Human
                                                                                                      used in administrative simplification                 Services.
                                              publish a notice in the Federal Register                transactions.
                                              announcing OMB’s decision to approve,                      The objectives of this hearing are as              ACTION: Notice.
                                              modify, or disapprove the proposed                      follows: (1) Review currently adopted
                                              information collection provisions. An                   standards, operating rules, code sets and             SUMMARY:   In accordance with Section
                                              Agency may not conduct or sponsor,                      identifiers used in each of the HIPAA-named           10(a) of the Federal Advisory Committee
                                              and a person is not required to respond                 administrative simplification transactions            Act, Public Law 92–463, as amended
                                              to, a collection of information unless it               and evaluate the degree to which they meet            (5 U.S.C. App.), notice is hereby given
                                              displays a currently valid OMB control
                                                                                                      current industry business needs; and (2)              that two meetings are scheduled for the
                                                                                                      Identify transactions, standards, operating           Advisory Group on Prevention, Health
                                              number.                                                 rules, code sets and identifiers used in              Promotion, and Integrative and Public
                                              VI. Comments                                            administrative simplification that require            Health (the ‘‘Advisory Group’’). The
                                                                                                      changes, deletions or new versions in order
                                                 Interested persons may submit either                 to meet industry needs.                               meetings will be open to the public.
                                              electronic comments regarding this draft                   We invite the public to prepare and submit         Information about the Advisory Group
                                              guidance to http://www.regulations.gov                  written testimony on any and all areas                and the agendas for these meetings can
                                              or written comments to the Division of                  covered by this hearing. We also invite               be obtained by accessing the following
                                                                                                      testifiers to prepare and submit more                 Web site: http://
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                                              Dockets Management (see ADDRESSES). It
                                              is only necessary to send one set of                    extensive written testimony, in addition to           www.surgeongeneral.gov/initiatives/
                                                                                                      the oral testimony they will be providing             prevention/advisorygrp/index.html.
                                              comments. Identify comments with                        during the hearing. Written testimonies
                                              Docket No. FDA–2015–D–1176.                             should be sent to Marietta Squire, Committee          DATES: The first meeting will be held on
                                              Received comments may be seen in the                    Management Specialist, Centers for Disease            June 11, 2015, from 11:30 a.m. to 2:30
                                              Division of Dockets Management                          Control and Prevention, National Center for           p.m. EST. The second meeting will be
                                              between 9 a.m. and 4 p.m., Monday                       Health Statistics, email msquire@cdc.gov.             held on August 31 from 9:00 a.m. to


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Document Created: 2015-12-15 15:29:48
Document Modified: 2015-12-15 15:29:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; withdrawal.
DatesAlthough you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 17, 2015. Submit written or electronic comments on the proposed collection of information by August 17, 2015.
ContactWith regard to this draft guidance: Division of Compliance, Center for Veterinary Medicine, Food and Drug Administration (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240- 402-7001, [email protected]
FR Citation80 FR 28624 

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